CN114828757A - Retractor members and related systems and methods - Google Patents
Retractor members and related systems and methods Download PDFInfo
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- CN114828757A CN114828757A CN202080088825.7A CN202080088825A CN114828757A CN 114828757 A CN114828757 A CN 114828757A CN 202080088825 A CN202080088825 A CN 202080088825A CN 114828757 A CN114828757 A CN 114828757A
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Abstract
A retractor member is configured for insertion through a channel of an access member and moving soft tissue at a treatment site accessible through the channel. The retractor includes a body having a proximal end and a distal end and being spaced from each other in a longitudinal direction. The distal end defines a retractor blade and the body defines first and second surfaces opposite one another along a transverse direction substantially perpendicular to the longitudinal direction. The retractor includes an attachment device configured to selectively attach the body to a portion of the access member such that the body is extendable through the working channel when the body is attached to the portion of the access member.
Description
Technical Field
The present invention relates to retractor members for retracting soft tissue at a surgical treatment site within a patient's anatomy, and systems and methods related to positioning the retractor members relative to an access tube.
Background
The access tube and/or retractor can be used to provide the physician with access to a surgical treatment site within the patient's anatomy or a "working channel". Various minimally invasive procedures may be performed through such access ports, including spinal procedures such as decompression, fusion, external fixation, and the like. The access tubes used in these procedures must typically be fixed in position relative to the treatment site via external devices, such as, by way of non-limiting example, operative desktop-mounted devices and/or anatomically mounted devices, such as bone anchors, including pedicle anchors, and the like. Once the access tube is positioned relative to the patient anatomy so as to provide a working channel open to the target treatment site, a retractor member (also referred to as a "retractor blade" or simply "blade") can be inserted through the working channel and manipulated to engage and pull soft tissue at the treatment site toward the wall of the access tube. Additional retractor members may be inserted through the working channel as needed to pull additional soft tissue toward the wall of the access tube. In this manner, soft tissue may be retracted from the treatment site, providing increased access and visualization of the treatment site, including visualization of the exiting nerve, to the physician. However, during surgical procedures, some soft tissue may tend to move or "creep" into the distal opening of the access tube, which may hinder visualization of the treatment site, including visualization of the exiting nerve.
Disclosure of Invention
In accordance with an embodiment of the present disclosure, a retractor member includes a body having a proximal end and a distal end and being spaced from each other along a longitudinal direction, the retractor member being configured for insertion through a channel of an access member and moving soft tissue at a treatment site accessible through the channel. The distal end defines a retractor blade and the body defines first and second surfaces opposite one another along a transverse direction substantially perpendicular to the longitudinal direction. The retractor includes an attachment device configured to selectively attach the body to a portion of the access member such that the body is extendable through the working channel and translatable in the longitudinal direction relative to the access member when the body is attached to the portion of the access member.
The body can have first and second sides spaced from each other along a lateral direction substantially perpendicular to the longitudinal and transverse directions, and the attachment device can extend from at least one of the first and second sides at a longitudinal portion of the body intermediate the proximal and distal ends such that the attachment device is configured to reside within the working channel for securing the retractor member to the inner surface of the access member.
The attachment device may include a pair of wings each extending circumferentially from the first side and the second side, respectively, at the longitudinal location, wherein the pair of wings are compliant and configured to flex inwardly toward each other from an intermediate configuration to a flexed configuration by the inner surface of the access member when the pair of wings are seated in the channel such that a return force of the pair of wings causes the pair of wings to engage the inner surface of the access member so as to attach the body to the portion of the access member.
The second surface of the body may define a first radius at the longitudinal portion and in a plane orthogonal to the longitudinal direction, and the outer surfaces of the wings may define another radius that is greater than the first radius when the pair of wings are in the intermediate configuration.
The body may define a proximal body portion extending from the pair of wings to the proximal end, and a distal body portion extending from the pair of wings to the distal end along the longitudinal direction, and the distal body portion and the proximal body portion may be at least partially circumferentially offset from one another.
The distal body portion and the proximal body portion may be fully circumferentially offset from one another.
The attachment device may include an attachment member separate from the body, wherein the attachment member includes:
a slide formation configured to slidably engage a complementary slide formation of the body so as to allow the attachment member to translate along the body and within the channel; and
a locking member extending circumferentially away from the sliding formation, wherein the locking member may be compliant and configured to flex inwardly toward a central axis of the entry member when the locking member is seated in the channel such that a return force of the locking member urges the locking member to engage the inner surface of the entry member to attach the body to the portion of the entry member.
The complementary slide formation of the body may comprise a guide slot, the locking member may comprise a circumferential wall configured to annularly slide between the outer surface of the body and an inner surface of the access member, wherein the slide formation of the attachment member may comprise a slider configured to reside within the guide slot, wherein the slider may extend inwardly from the circumferential wall in the transverse direction.
The attachment device may include an attachment member separate from the body, at least a portion of the attachment member may include a magnetic material, and the body may include one or more magnets each configured for selective attachment to the magnetic material of the at least a portion of the attachment member.
The body may define an interior chamber, and may further define a proximal port and a plurality of vacuum ports each in fluid communication with the interior chamber, wherein the plurality of vacuum ports may be defined in the second surface, and the proximal port may be connectable to a vacuum source; and is
The attachment device may include a plurality of ring seals each seated in one of the plurality of vacuum ports, wherein the plurality of ring seals may be configured to sealingly engage an inner wall surface of the access member when vacuum pressure is supplied within the interior chamber.
The attachment device may include a wire configured to transition from an insertion configuration to a deployed configuration, wherein the wire is configured to be contained within an elongated insertion device when in the insertion configuration, and the wire is further configured to spring outward so as to extend at least partially circumferentially around an inner wall surface of the access member so as to force the body toward the inner wall surface when in the deployed configuration.
The body may have first and second sides spaced from each other along a lateral direction substantially perpendicular to the longitudinal and transverse directions, the first surface may be arcuate and concave between the first and second sides in a plane orthogonal to the longitudinal direction, and the second surface may be arcuate and convex between the first and second sides in the plane.
At least at one of the proximal end and the distal end, the body can define a flared end portion such that the end portion defines a maximum lateral dimension that is greater than a maximum lateral dimension of an adjacent portion of the body that extends from the end portion toward the opposite one of the proximal end and the distal end.
At least at one of the proximal end and the distal end, the body may define an end portion that is angularly offset from an adjacent portion of the body that extends from the end portion toward the opposite one of the proximal end and the distal end.
The end portion may be angularly offset from the adjacent portion of the body.
At least a proximal portion of the body may be plastically deformable to bend away from a central axis of the access member after the body is attached to the portion of the access member.
The body may include at least one conductive sensor at the distal end, and the at least one conductive sensor may be in electrical communication with an electrical lead spaced from the at least one conductive sensor, and may be configured to communicate sensor information obtained by the at least one sensor to a control unit.
The body can be formed of an electrically conductive material, and the retractor member can further include electrical insulation covering a major portion of the body, wherein the body can include a distal exposed portion at the distal end that can define the at least one electrically conductive sensor, the body can further include a proximal exposed portion at the proximal end, and the proximal exposed portion can define the electrical lead.
The body may be formed of an electrically insulating material, and the at least one electrically conductive sensor may be embedded in the body at the distal end.
In accordance with another embodiment of the present disclosure, a system for retracting soft tissue includes an access member having a proximal end and a wall extending from the proximal end to a distal end of the access member. The wall extends about a central axis in a plane orthogonal to the central axis such that an inner surface of the wall defines a channel extending in an axial direction, the axial direction being oriented along the central axis. The system includes a retractor body having a proximal end and a distal end configured to engage soft tissue and spaced from the proximal end of the retractor body in a longitudinal direction. The retractor body defines a first surface and a second surface opposite one another along a transverse direction substantially perpendicular to the longitudinal direction. The system includes an attachment device coupled to the retractor body and including proximal and distal mounts configured to be mounted to the proximal and distal ends of the access member, respectively. At least one of the proximal mount and the distal mount is configured to move between: a non-locking configuration wherein the proximal mount and the distal mount are longitudinally spaced from one another by a first distance; and a locked configuration, wherein the proximal mount and the distal mount are longitudinally spaced from one another by a second distance that is less than the first distance. The second distance corresponds to a distance between the proximal end and the distal end of the access member in the axial direction.
The proximal mount and the distal mount may each include a hook configured to hook over respective proximal and distal ends of the access member.
The retractor body may be longitudinally translatable relative to the proximal mount and the distal mount at least when the attachment device is in the locked configuration.
The system may further include an actuator configured to actuate the at least one of the proximal mount and the distal mount from the unlocked configuration to the locked configuration.
The actuator may include at least one elongate member extending from the distal mount through the receptacle of the proximal mount and to a control member spaced from the proximal mount in a proximal direction oriented in the longitudinal direction, wherein the control member may be configured to be manipulated to actuate the at least one of the proximal mount and the distal mount from the unlocked configuration to the locked configuration.
The retractor body can define a slot extending in the longitudinal direction, and each of the proximal mount and the distal mount can include a sliding member extending within the slot and can be configured to slide longitudinally along the slot so as to guide longitudinal movement of the respective mount relative to the retractor body.
The retractor body can further define a series of ratchet grooves arranged longitudinally along the slot, and the proximal mount can include a flexible member having teeth configured to engage the series of ratchet grooves, wherein the flexible member can be configured to alternate between: 1) an intermediate configuration wherein the tooth resides within one of the ratchet grooves so as to maintain a relative longitudinal position between the proximal mount and the retractor member; and 2) a disengaged configuration in which the teeth are distal from each ratchet groove of the series of ratchet grooves.
The proximal mount may comprise a handle portion.
The system may further include an instrument releasably coupled to the attachment device, the instrument may include:
a handle extending from a rear end of the instrument to a front end of the instrument; and
a coupling mechanism at least partially located at the leading end of the instrument, the coupling mechanism configured to alternate between: 1) a coupling configuration in which
The instrument is rigidly coupled to the retractor body; and 2) an uncoupled configuration, wherein the instrument is uncoupled from the retractor body and is removable from the retractor body.
The coupling mechanism may be further configured to move the actuator so as to actuate the at least one of the proximal mount and the distal mount from the unlocked configuration to the locked configuration.
The proximal mount may include a mounting base and an engagement member, wherein the actuator may extend between the mounting base and the engagement member and may be configured to actuate longitudinal movement of the engagement member relative to the mounting base between the unlocked configuration and the locked configuration.
The actuator may include a biasing mechanism having at least one spring biasing the engagement member in a biasing direction away from the mounting base along the longitudinal direction to actuate the engagement member to the locked configuration;
the biasing mechanism may further include a return member configured to move the engagement member toward the mounting base and into the unlocked configuration in a direction opposite the biasing direction; and is
The coupling mechanism may include a moving member configured to move the return member in a direction opposite to the biasing direction.
The retractor body can include an aperture and the coupling mechanism can include a pin configured to 1) reside within the aperture to couple with the retractor member when the coupling mechanism is in the coupled configuration; and 2) move away from the aperture to decouple from the retractor member when the coupling mechanism is in the decoupled configuration.
The coupling mechanism may include a button connected to the pin and may be configured to alternate between a first position in which the pin resides within the aperture and a second position in which the pin is remote from the aperture.
The actuator may be a tensile member configured to selectively apply tension between the proximal mount and the distal mount so as to actuate the at least one of the proximal mount and the distal mount.
In accordance with additional embodiments of the present disclosure, a system for retracting soft tissue includes an access member having a proximal end and a wall extending from the proximal end to a distal end of the access member. The wall extends about a central axis in a plane orthogonal to the central axis such that an inner surface of the wall defines a channel extending in an axial direction, the axial direction being oriented along the central axis. The system includes a retractor body having a proximal end and a distal end configured to engage soft tissue and spaced from the proximal end of the retractor body in a longitudinal direction. The retractor body defines a first surface and a second surface opposite one another along a transverse direction substantially perpendicular to the longitudinal direction. At least one of the access member and the retractor body defines one or more openings, and the other of the access member and the retractor body includes one or more protrusions that are complementary to the one or more openings and are configured for insertion within the one or more openings to couple the retractor body to the access member.
Each of the one or more protrusions may define a shank and a head extending outwardly from the shank, the head being wider than the shank.
The one or more openings may comprise an array of openings extending outwardly from an inner surface of the wall into the wall, the array may define a plurality of columns, each of the columns comprising a longitudinally aligned subset of the plurality of openings, wherein the columns may be circumferentially spaced from each other along the wall,
the one or more protrusions can include a plurality of protrusions that each extend from the second surface of the retractor member in the transverse direction and are aligned with each other in the longitudinal direction, wherein the plurality of protrusions can be configured to selectively reside within at least one of the columns such that the head overlaps at least a portion of the wall in the axial direction.
The retractor body can have a proximal portion and a distal portion configured to be angularly offset from one another in a plane extending in the longitudinal and transverse directions, and at least one of the one or more openings can extend through the proximal portion from the first surface to the second surface, and
the one or more protrusions may include a plurality of protrusions extending in the longitudinal direction from a proximal surface of the access member, wherein the proximal surface may be located at a proximal end of the access member, and the plurality of protrusions may be circumferentially spaced from one another along the proximal surface.
Drawings
The foregoing summary, as well as the following detailed description of exemplary embodiments of the present application, will be better understood when read in conjunction with the appended drawings. To illustrate the structure of the present application, illustrative embodiments are shown in the drawings. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings:
fig. 1A is a perspective view of a spinal surgical system including a surgical access system, according to an embodiment of the present disclosure;
FIG. 1B is another perspective view of the spinal surgical system illustrated in FIG. 1A, the perspective view showing the working channel of the tubular access member of the surgical access system;
fig. 1C is a perspective view of the surgical access system shown in fig. 1B showing a retractor positioned within a working channel of an access member with a proximal portion of the retractor bent relative to a distal portion of the retractor and facing away from the working channel, in accordance with an embodiment of the present disclosure;
FIG. 1D is a partial top view of the access member shown in FIG. 1C having a retractor attached to an inner wall surface of the access member;
fig. 2A is a perspective view of a retractor including straight ends and including flexible attachment springs for securing the retractor to an inner wall surface of the access member shown in fig. 1A-1C, according to an embodiment of the present disclosure;
fig. 2B is a perspective view of a retractor having angularly offset ends and otherwise similar to that shown in fig. 2A, according to an embodiment of the present disclosure;
FIG. 2C is a partial side view of the retractor shown in FIG. 2B;
fig. 2D is a perspective view of a retractor having a flared end and otherwise similar to that shown in fig. 2A, according to an embodiment of the present disclosure;
fig. 2E is a perspective view of a retractor having flared and angled offset ends and otherwise similar to that shown in fig. 2A, according to an embodiment of the present disclosure;
FIG. 2F is a perspective view of a retractor having a flexible attachment spring and proximal and distal portions circumferentially offset from one another along the attachment spring;
FIG. 2G is a perspective view of a retractor defining a plurality of apertures;
FIG. 3A is a perspective view of a surgical access system having an access member and a retractor with a guide feature for guiding movement of a separate attachment spring;
figure 3B is a perspective view of the surgical access system shown in figure 3A showing an attachment spring in a position distal to the access member connected to a guide feature of the retractor;
figure 3C is a perspective view of the surgical access system shown in figure 3B showing the attachment spring advanced distally along the guide feature to a position within the working channel of the access member, wherein the attachment spring securely pushes the retractor against the inner wall surface of the access member.
Fig. 3D is a perspective view, partially in section, of a surgical access system having an access member, a retractor and a separate attachment spring carrying one or more magnets for magnetic attachment to the retractor, in accordance with an embodiment of the present disclosure;
fig. 4A is a perspective view of a surgical access system including an instrument in a coupled configuration with an attachment device of a retractor in which the instrument can manipulate the retractor for engaging and retracting soft tissue through a working channel, and showing the attachment device in a locked configuration with an access member operable by the instrument for attaching the retractor to a selected circumferential position of the access member, the attachment device further configured to allow the retractor to translate longitudinally relative to the access member when the attachment device is in the locked configuration, according to an embodiment of the present disclosure.
Fig. 4B is another perspective view of the surgical access system shown in fig. 4A in a coupled and locked configuration;
FIG. 4C is a side view of a portion of the instrument illustrated in FIG. 4A, showing a portion of the coupling mechanism of the instrument in a coupled configuration with the attachment device, and also showing the proximal mount of the attachment device in a locked configuration with the access member;
FIG. 4D is a side view of the portion of the instrument shown in FIG. 4C, showing portions of the coupling mechanism in an uncoupled configuration, wherein the instrument is uncoupled from the attachment device; also shown is a proximal mount that is held in a locked configuration with the access member;
fig. 4E is a cross-sectional side view of the surgical access system shown in fig. 4A, showing the proximal mount alternating between a locked configuration and a non-locked configuration relative to the access member;
FIG. 4F is a cross-sectional perspective view of the biasing mechanism of the attachment device shown in FIG. 4A;
FIG. 4G is a cross-sectional perspective view of the coupling mechanism of the instrument illustrated in FIG. 4A;
FIG. 4H is a cross-sectional perspective view of the coupling mechanism shown in FIG. 4A;
FIG. 4I is a cross-sectional perspective view of the attachment device decoupled from the instrument shown in FIG. 4A, the cross-sectional perspective view showing the retractor longitudinally translatable relative to the attachment device and the access member;
figure 4J is a perspective view of the attachment device shown in figure 4I showing a guide feature for guiding translation of the retractor relative to the access member;
FIG. 4K is another perspective view of the guide feature shown in FIG. 4J;
fig. 5A is a perspective view of another embodiment of an instrument releasably coupled to a retractor, wherein the instrument is directly coupled to the retractor, the retractor carries an attachment device for attaching the retractor to a selected circumferential location of an access member, and the attachment device is operable independently of the instrument;
FIG. 5B is a cross-sectional perspective view of the coupling mechanism of the instrument taken along section line 5B-5B shown in FIG. 5A;
FIG. 6A is a side plan view of another embodiment of an instrument releasably coupled to a retractor, wherein the retractor includes an attachment device that employs a tension actuator for attaching the retractor to a selected circumferential location of an access member;
fig. 6B is a rear plan view of the distal mount of the attachment device shown in fig. 6A, with the distal mount actuated by a tension actuator;
FIG. 6C is a perspective view of the attachment device shown in FIG. 6A;
fig. 6D is a side plan view of the surgical access system showing the instrument, retractor, and attachment device of fig. 6A attached to an access member;
FIG. 6E is a perspective view of the proximal mount of the attachment device shown in FIG. 6A, the perspective view showing the proximal mount with receiving formations for receiving a tension actuator;
fig. 6F is a bottom plan view of the distal mount and retractor blade shown in fig. 6B;
fig. 7A is a perspective view of a retractor having an attachment device with a handle member and employing a ratchet mechanism according to an embodiment of the present disclosure;
FIG. 7B is a perspective view of another embodiment of the handle member shown in FIG. 7A;
FIG. 7C is a cross-sectional perspective view of the attachment device taken along section line 7C-7C shown in FIG. 7A;
figure 7D is a perspective view of the retractor and attachment device shown in figure 7A;
FIG. 7E is a cross-sectional perspective view of the retractor and attachment device taken along section line 7E-7E shown in FIG. 7D;
FIG. 7F is a perspective view of the ratchet mechanism shown in FIG. 7A;
FIG. 7G is a rear plan view of the pawl of the ratchet mechanism shown in FIG. 7A, with the handle member broken away for visibility purposes;
FIG. 7H is a cross-sectional perspective view of the pawl taken along section line 7H-7H shown in FIG. 7G;
fig. 8A is a cross-sectional view of a retractor having suction attachment means for attaching the retractor to a selected circumferential location of an access member according to an embodiment of the present disclosure;
figure 8B is a rear plan view of the retractor shown in figure 8A;
FIG. 8C is a cross-sectional end view of the retractor taken along section line 8C-8C shown in FIG. 8B;
fig. 9A is an exploded partial cross-sectional view of a surgical access system having an attachment device including a protrusion and a complementary opening configured for selective mating engagement to attach a retractor to a selected circumferential location of an access member, according to an embodiment of the present disclosure;
FIG. 9B is a cross-sectional side view showing the mating engagement between the protrusion and opening shown in FIG. 9A;
FIG. 9C is a cross-sectional side view showing an alternative mating engagement between the protrusion and opening shown in FIG. 9A;
FIG. 9D is a perspective view of an access member having a proximal surface and a series of protrusions circumferentially arranged along the proximal surface for selective mating engagement with complementary openings in a retractor;
figure 9E is a cross-sectional side view of the retractor in close mating engagement with the access member shown in figure 9D;
fig. 10A is a partial cross-sectional view of a surgical access system including an introducer for inserting a flexible wire attachment device, shown in an insertion configuration, into a working channel of an access member, according to an embodiment of the present disclosure;
fig. 10B is a cross-sectional view of the surgical access system shown in fig. 10A, the cross-sectional view showing the flexible wire attachment device in an expanded configuration, wherein the flexible wire attachment device secures the retractor to the inner wall surface of the access member;
fig. 10C is a front view of another embodiment of the flexible wire attachment device loaded in the introducer in an insertion configuration;
FIG. 10D is a front plan view of the flexible wire attachment device shown in FIG. 10C shown in an expanded configuration;
FIG. 11A is a front plan view of a retractor having an electrically insulating sheath and also having sensors for obtaining electrical information at a surgical treatment site;
FIG. 11B is a front plan view of a retractor constructed of an electrically insulating material and having sensors for obtaining electrical information at a surgical treatment site;
figure 12A is a perspective view of an instrument carrying a retractor including a tether according to another embodiment of the present disclosure;
FIG. 12B is a perspective view of the retractor shown in FIG. 12A;
figure 12C is a perspective view of a retractor having an alternative tether according to another embodiment of the present disclosure;
fig. 12D is a perspective view of a surgical access system having a housing formation for connecting to a tether employing the retractor illustrated in fig. 12A, in accordance with an embodiment of the present disclosure; and is
Fig. 12E is a perspective view of the surgical access system shown in fig. 12D having a retaining clip for connecting to a tether, according to another embodiment of the present disclosure.
Detailed Description
The disclosure may be understood more readily by reference to the following detailed description taken in conjunction with the accompanying drawings and examples which form a part hereof. It is to be understood that this disclosure is not limited to the particular devices, methods, applications, conditions or parameters described and/or illustrated herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to limit the scope of the present disclosure. Furthermore, as used in this specification (including the appended claims), the singular forms "a," "an," and "the" include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise.
The term "plurality" as used herein means more than one. When a range of values is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. All ranges are inclusive and combinable.
As used herein, the terms "about" and "substantially" with respect to dimensions, angles, and other geometries account for manufacturing tolerances. Further, the terms "about" and "substantially" may include greater than or less than 10% of the stated dimension or angle. Further, the terms "about" and "substantially" are equally applicable to the particular values recited.
The embodiments described below relate to retractor components (also referred to herein as "retractors") for use in surgical access systems that include an access component, such as an access tube. In particular, the embodiments described below relate to retractors configured for insertion through a working channel of an access member to engage and retract soft tissue at a surgical treatment site located distal to the working channel. More specifically, the embodiments described below include various attachment devices that allow for selective attachment of the retractor to a circumferential location of the access tube, thereby securing the soft tissue in the retracted position. As used herein with reference to an access member, the term "circumferential" generally refers to a direction of rotation about a central axis of the access member, and particularly refers to any direction having a directional component that is offset from both (1) a radial direction perpendicular to the central axis and (2) an axial direction in which the central axis extends. Thus, the term "circumferential" as used herein with reference to the access member refers to a direction along any of a line, arc, circle, ellipse, polygon, or irregular shape that rotates at least partially about the central axis of the access member.
Some of the attachment devices described below are located entirely on the retractor, while others are used in complementary components or features of the retractor and the access member, while still others are used in separate components of the surgical access system. Additionally, most of the attachment devices described below allow the retractor to move relative to the access member while remaining secured to its inner wall surface as follows: translating in an axial direction, the axial direction being oriented along a central axis of the member; and rotation (rotation) around the central axis along the inner wall surface. These movements allow the physician to adjust the retractor position within the working channel as needed to account for changes in the patient's anatomy (e.g., changes between anatomies of different patients). Such retractors and complementary attachment devices, which may be moved in any of the foregoing ways, may also be repositioned during a surgical procedure to adjust the retraction of soft tissue as desired while still remaining attached to the inner wall such that when the physician has repositioned the retractor to a satisfactory position, the attachment devices will maintain the position of the retractor relative to the access member after the physician releases the retractor.
In additional embodiments described below, the retractor is used as part of a surgical access system that includes instruments coupled to a proximal end of the retractor and configured for manipulating the retractor to engage soft tissue. The instruments described below are configured to selectively couple and decouple with the retractor as desired. In other embodiments, the insertion instrument is further configured to actuate the attachment device from an unattached configuration in which the attachment device is unattached to the access member to an attached configuration in which the attachment device attaches the retractor to the access member, as described above.
Referring now to fig. 1A, an exemplary embodiment of a surgical access system 100 for spinal surgery includes an access member 102 for providing access to a surgical treatment site within a patient, and a retractor member 2 configured to extend through the access member 102 and engage soft tissue at the treatment site. Access member 102 has a body 103, which may be tubular, and is configured to extend distally relative to the patient's anatomy from an extracorporeal location to an intracorporeal target location within the patient's anatomy. By way of non-limiting example, the access member 102 may be configured to extend through the skin line 90 and to a target location at or adjacent to the intended surgical treatment site. The access member 102 includes a housing or wall 104 defining an internal port or passage 106 (also referred to herein as a "working passage" 106) that is elongated along a central axis 108 of the access member 102 and opens in an axial direction X (i.e., a direction oriented along the central axis 108) from an extracorporeal location to a target location. The access member 102 extends in an axial direction X from a proximal end 110 to a distal end 112. In the example shown, the central axis 108 defines a spinal access axis oriented along a transforaminal access, such as through Kambin's triangle. In this example, the target location of the access member 102 is at the facet line 92 of the adjacent vertebral bodies 94 and the treatment site includes the disc space 96. However, it should be understood that other approaches are within the scope of the present disclosure, including but not limited to interlaminar, lateral, and anterior approaches. With the access member 102 positioned at an appropriate depth and orientation to extend to the treatment site, the central axis 108 intersects the treatment site. In this manner, the instrument can be advanced distally toward the treatment site through the access member 102 as desired. To prepare the treatment site for certain instruments, one or more retractor members 2 may be inserted through working channel 106, such as along central axis 108, and may be manipulated to engage and retract soft tissue (including soft tissue near the exiting nerve), such as by pulling or otherwise moving the soft tissue away in radial direction R and substantially perpendicular to central axis 108 (and thus also substantially perpendicular to axial direction X). If a portion of the engaged soft tissue extends within the working channel, the retraction moves this soft tissue toward the wall 104 of the access member 102. Among other things, retraction of soft tissue can be used to expose and provide visualization of the emanating nerve so that a physician can avoid damaging or contacting the emanating nerve during spinal surgery.
Referring now to fig. 1B-1D, the wall 104 of the entry member 102 defines an outer wall surface 114 and an inner wall surface 116 spaced from each other in the radial direction R. As shown, the outer wall surface 114 may have an elliptical profile in a plane orthogonal to the central axis 108. In addition, the wall 104 may also define a secondary channel 107 along the axial direction X. For example, the inner wall surface 116 may define one or more protrusions 117 extending generally radially inward toward the central axis 108 to define a separation between the working channel 106 and the secondary channel 107. In the embodiment shown, by way of non-limiting example, secondary channel 107 may house one or more optical instruments, such as a camera or other type of image sensor. In such embodiments, the separation between working channel 107 and secondary channel 107 helps prevent mechanical interference between the optical instrument and any instrument extending through working channel 106. The secondary channel 107 preferably opens at least in a direction having a directional component in the radial direction R to the working channel 106. As shown, the wall 104 may extend a full turn about the central axis 108, providing the access member 102 with its tubular configuration. It should be appreciated, however, that the wall 104 may extend less than a full turn about the central axis 108 while continuing to provide the working channel 106, and optionally also the secondary channel 107.
As shown in fig. 1C, a retractor member 2 (also referred to herein as a "retractor" 2) has a retractor body 3 that extends from a proximal end 4 to a distal end 6 that are spaced apart from each other along a longitudinal direction L. It will be understood that, by way of non-limiting example, the retractor body 3 may define the entire retractor 2 in a unitary manner, or may define a portion of the retractor 2, such as a major portion thereof, in combination with one or more separate but connected (or connectable) portions of the retractor 2. The distal end 6 may have a blade-like geometry and may therefore be referred to as a "retractor blade", or simply a "blade". The retractor 2 has a length in the longitudinal direction L that is greater than the length of the access member 102 in the axial direction X. In this manner, the retractor 2 can be inserted through the working channel 106 to a treatment site and manipulated through its proximal end 4 in order to control placement of the distal end 6 to engage soft tissue as desired at or near the treatment site. It will be appreciated that proximal end 4 may also have a blade-like geometry, and thus may also be referred to as a "retractor blade" or "blade". Such a counter-blade configuration may be advantageous because it does not necessarily require a particular end to be inserted through the access member 102.
With soft tissue engaged, the retractor 2 can be moved to an inner wall surface 116, described in more detail below, and attached thereto by an attachment device. As shown in fig. 1D, the retractor body 3 has a first or "inner" surface 10 and a second or "outer" surface 12 spaced from each other along a transverse direction T substantially perpendicular to the longitudinal direction L. The outer surface 12 of the retractor body 3 is preferably arcuate and convex in a plane orthogonal to the longitudinal direction L. Additionally, the outer surface 12 preferably defines a radius R1 that is substantially equal to the radius R2 of the inner wall surface 116. In this way, the retractor body 3 can move flush with the inner wall surface 116 for connection thereto so as to avoid blocking the working channel 106. It will be appreciated that the transverse direction T is oriented substantially in the radial direction R of the access member 102 when the retractor body 3 is flush with the inner wall surface 116. The inner surface 10 of the retractor body 3 is preferably arcuate and concave in an orthogonal plane, and preferably extends parallel or concentric with the convex outer surface 12 in an orthogonal plane.
The retractor 2 is formed of a biocompatible material (i.e., "biomaterial") and is sufficiently rigid such that manipulation at the proximal end 4 causes retraction of soft tissue at the distal end 6 (or vice versa with insertion of the opposite end through the working channel 106). The material also preferably provides deformability to the retractor body 3, such as via plastic deformation, allowing the first portion 3a of the retractor body 3 to bend relative to the second portion 3b of the retractor body, as illustrated in fig. 1C. In this way, when the retractor body 3 has achieved satisfactory retraction of soft tissue (and the retractor body 3 has been secured to the access member 102 by the attachment device, as described in more detail below), the practitioner can bend the first portion 3a away from the central axis 108 and away from the path, thereby reducing the profile of the retractor body 3 in the proximal direction P. By way of non-limiting example, such retractor body materials can be metal (e.g., stainless steel, such as 300 series and/or 400 series stainless steel), polymer (e.g., polyphenylsulfone (PPSU)), and/or composite material (e.g., carbon fiber).
Referring now to fig. 2A-2F, different variants of the retractor body 3 are shown, each of which includes an integrated attachment device 14 for coupling the retractor body 3 to the wall 104 of the access member 102. For example, the attachment device 14 is configured to attach the retractor body 3 to a circumferential portion of the inner wall surface 116 as selected by the physician. Specifically, the attachment device 14 illustrated in each of these variations includes at least one compliant member 16 configured to flex from an intermediate configuration when disposed outside of the working channel 106 to a flexed configuration when inserted within the working channel 106. The compliant member 16 may also be referred to as a "locking spring" or "locking ring". When in the flexed configuration, the compliant member 16 applies a return force (which may also be referred to as a "locking force") to the inner wall surface 116 sufficient to urge the retractor body 3 toward the inner wall surface 116, effectively securing the retractor body 3 in position relative to the wall 104. It will be appreciated that the compliant member 16 is configured such that the locking force is sufficient to maintain retraction of the soft tissue engaged by the distal end 6 of the retractor body 3, but not so great as to prevent the practitioner from subsequently further manipulating the retractor body 3 to adjust engagement with the soft tissue, such as translating the retractor body 3 in the axial direction X, rotating the retractor body 3 about the central axis 108, or any combination of the foregoing. Further, the compliant member 16 of this embodiment is configured to effectively automatically secure the retractor body 3 in place within the working channel 106 (so long as the compliant member 16 resides within the working channel 106) when the physician has finished manipulating the proximal end 4 of the retractor body.
Each of the retractor bodies 3 defines a first side 20 and a second side 22 spaced from each other along a lateral direction a substantially perpendicular to the longitudinal direction L and the transverse direction T. The compliant members 16 of the attachment device 14 can include a pair of compliant members 16 or "wings" extending circumferentially outward from the first and second sides 20, 22 at a longitudinal portion 3c of the retractor body 3 intermediate its proximal and distal ends 4, 6. Thus, the longitudinal portion 3c may also be referred to as the "middle" portion 3c of the retractor body 3. The retractor body 3 further defines a proximal body portion 3D extending from the intermediate portion 3c to the proximal end 4 in the proximal direction P, and a distal body portion 3e extending from the intermediate body portion 3c to the distal end 6 in the distal direction D. It will be appreciated that the proximal direction P and the distal direction D are each unidirectional components of the longitudinal direction L (which is bidirectional). The radially outer surface of the wings 16 define a radius R3 that is slightly larger than the radius R2 of the inner wall surface 116 when in the intermediate configuration. In this manner, insertion of the wings 16 into the working channel 106 causes the wings 16 to flex inwardly toward the central axis 108 (and also toward each other), thereby providing a locking force. One or both of the wings 16 may define a helical end surface 18 connected to a respective first side 20 or second side 22 of the retractor body 3. In the illustrated embodiment, the helical end surface 18 defines a proximal surface of each wing 16, but the distal surface of one or both of the wings 16 may also extend helically to the respective first or second side 20, 22 in a similar manner.
As shown in fig. 2B and 2C, the retractor body 3 may define a proximal end portion 3f that is angularly offset from an adjacent portion 3h by an acute angle α 1 as measured in a plane extending in the longitudinal direction L and the transverse direction T, which may be referred to as an "L-T plane". The adjacent portion 3h can be characterized as a portion of the body 3 extending from the end portion 3f of the retractor body 3 towards the opposite end 6. The retractor body 3 may alternatively or additionally define a distal end portion 3g that is angularly offset from the adjacent portion 3h by an acute angle a2 in the L-T plane. In embodiments where the retractor body 3 has proximal and distal portions 3f, 3g angularly offset from the adjacent portion 3h, the acute offset angles a1, a2 may be substantially equal, as shown, or may be different from each other.
As shown in fig. 2D, one or both of the proximal end portion 3f and the distal end portion 3g may flare outwardly in the lateral direction a so as to define a maximum lateral dimension a1, a2 that is greater than a maximum lateral dimension A3 of the adjacent portion 3 h. In embodiments where both the proximal end portion 3f and the distal end portion 3g flare outwardly in the lateral direction a, the maximum lateral dimensions a1, a2 of the end portions 3f, 3g may be substantially equal (as shown), or may be different from each other.
As illustrated in fig. 2E, one or both of the proximal end portion 3f and the distal end portion 3g can be angularly offset from the adjacent portion 3h and flare outwardly in a lateral direction a relative to the adjacent portion 3 h. For example, both the proximal end portion 3f and the distal end portion 3g may be angularly offset from the adjacent portion 3h at the same or different acute angles, and may also be flared outwardly to define the same or different maximum lateral dimensions. It should be appreciated that the retractor body 3 may have a proximal end portion 3f and a distal end portion 3g as any combination of the foregoing (i.e., straight, angled, and flared).
Referring now to fig. 2F, the proximal body portion 3d and the distal body portion 3e may be at least partially, and optionally fully, circumferentially offset from one another. In such embodiments, the proximal body portion 3D may extend from the proximal end 4 to the locking spring 16 in the distal direction D, and the distal body portion 3e may extend from the locking spring 16 to the distal end 6 in the distal direction D. Additionally, in such embodiments, the locking spring 16 may include an interconnecting portion 16a that connects the proximal body portion 3d with the distal body portion 3 e.
As shown in fig. 2G, the retractor body 3 may include one or more features for increasing the flexibility of its respective body portion. By way of non-limiting example, the retractor body 3 may define an aperture 24 extending therefrom in the transverse direction T, such as for facilitating plastic deformation in the L-T plane, such as for bending the proximal portion 3a of the body 3 out of the path when secured to the wall 104, as described above with reference to fig. 1C. For example, the aperture 24 may effectively define a bend enhancing zone of the retractor body 3. Additionally or alternatively, one or both of the wings 16 may define apertures 26 for increasing the degree of flexibility of the wings 16, such as for elastic deformation between the intermediate and flexed configurations described above. One advantage of using the apertures 24, 26 to increase the degree of flexibility is that stronger materials can be used to form the retractor body 3. Furthermore, the shape of the aperture 26 may be elliptical, which may reduce material fatigue due to multiple bends applied at or near the same location of the retractor body 3. Additionally, at one or both of the proximal end 4 and the distal end 6, the retractor body 3 may define an end formation 27 for connection to a wire, flexible tube, or other component or instrument of the surgical access system 100. Non-limiting examples of such end formations 27 may include apertures 28 and prongs 29 extending over the apertures 27, such as in the longitudinal direction X.
It will be appreciated that the locking spring 16 of any of the foregoing embodiments may be disposed at different longitudinal positions along the retractor body 3 to compensate for deflection in response to soft tissue engaged by the distal end 6 and/or other surrounding tissue in contact with the retractor 2. For example, any combination of retractors 2 described above with reference to fig. 2A-2G may be provided in a kit comprising multiple versions of each retractor 2, with respective locking springs 16 located at different longitudinal positions along the retractor body 3.
It will also be appreciated that the design of the retractor 2 described above with reference to fig. 2A-2G allows more than one retractor 2, such as two (2) or more retractors 2, to be inserted within the working channel 106 and secured to the inner wall surface 116 for retracting soft tissue. Upon inserting the second retractor 2 into the working channel 106 to which the first retractor 2 has been attached, the physician may select the second retractor 2 as the following retractor: wherein when both are secured within the working channel 106, their locking springs 16 will be longitudinally offset from the locking springs of the first retractor 2, thereby avoiding interference between the locking springs 16. Additionally or alternatively, the physician may select the second retractor 2 to have the same design as the first retractor, and may select to insert the opposite end of the second retractor 2 into the channel 106 (i.e., the second retractor 2 may be flipped relative to the first retractor 2) so that the locking springs 16 do not interfere with each other.
Referring now to fig. 3A-3C, in other embodiments, the attachment device 14 can include an attachment member 17 that is separate from the retractor 2 and can be connected to the retractor (such as before, during, or after insertion of the retractor 2 through the working channel 106). In such embodiments, the retractor 2 and the attachment member 17 may have complementary mounting formations. For example, the attachment member 17 may include a slide formation, such as a slider 30, configured to slidably engage a complementary slide formation, such as a guide slot 32, of the retractor body 3. The guide slot 32 of this embodiment guides the translational, longitudinal movement of the slider 30 (and thus also the attachment member 17) along the retractor body 3 into and out of the working channel 106 as desired. The slider 30 and the guide slot 32 preferably have complementary geometries that allow the slider 30 to enter the guide slot 32 and exit the guide slot 32 at least at one location of the guide slot 32, such as at a proximal end thereof. For example, the proximal end of the guide slot 32 may have a widened portion or opening that allows the slider 30 to pass in and out therein, while the retainer of the guide slot 32 is configured to retain the slider 30 therein. The distal end of the guide slot 32 may effectively provide a physical termination that prevents the slider 30 (and thus also the attachment member 17) from over-translating in the distal direction D.
Similar to the embodiments described above, the attachment member 17 includes a locking member, such as locking spring 16, that may be configured similarly to that described above. The locking spring 16 may define one or more compliant wings, each of which may be referred to as a circumferential wall that extends circumferentially away from the slide former 30 and is configured to flex inwardly toward the central axis 108 of the access member 102 to supply a locking force when the locking member 16 is seated in the working channel 106. When inside the working channel 106, the locking spring 16 can be positioned to annularly slide between the outer surface 12 of the retractor body 3 and the inner surface 116 of the access member 102. The slider 30 may extend inwardly from the locking spring 16 in the transverse direction T (i.e., toward the central axis 108 of the entry member 102) and into the guide slot 32. In other embodiments, the slider 30 can extend laterally outward from the lock spring 16, in which embodiment the retractor body 3 can be annularly positioned between the lock spring 16 and the inner wall surface 116. The attachment member 17 includes a gripping member, such as a proximal extension 34, that allows a physician to manipulate the attachment member 17 in the longitudinal direction L relative to the retractor body 3. It will be appreciated that the proximal extension 34 may be configured to curve away from the central axis 108 and deviate from the path so as to reduce its profile in the proximal direction P, similar to that described above with reference to fig. 1C.
The retractor body 3 of this embodiment is freely insertable through the working channel 106 to engage soft tissue and, once so engaged, may receive an attachment member 17 which may be advanced along the guide slot 32 in the distal direction D until the locking spring 16 resides at a desired longitudinal position within the working channel 106 where it provides a locking force. The longitudinal position of the attachment member 17 can thereafter be adjusted as needed to reduce deflection of the retractor in response to the surrounding tissue. Further, if subsequent adjustment of the engagement between the distal end 6 of the retractor body 3 and the soft tissue is desired, the attachment member 17 can be withdrawn proximally from the working channel 106 while optionally remaining engaged with the guide slot 32, and can be re-translated within the working channel 106 as desired, such as after adjustment of the soft tissue is complete. In this manner, the attachment member 17 can be withdrawn from the working channel 106 during readjustment of the soft tissue retraction, allowing the physician to more freely manipulate the retractor body 3 as desired.
Referring now to fig. 3D, in other embodiments, the separate attachment member 17 and retractor 2 can be configured to magnetically attach to each other within the working channel 106. For example, at least a portion of the locking spring 16 of the attachment member 17 can be constructed of a ferrous (e.g., magnetic) material, and the retractor 2 can include a series of magnets 35 for selective attachment to the attachment member 17 (or at least to a ferrous portion thereof). The attachment member 17 including the locking spring 16 and its proximal extension 34 may otherwise be similarly configured as described above with reference to fig. 3A-3C. In this embodiment, the attachment member 17 may be inserted into the working channel 106, and then the retractor 2 may be inserted through the working channel 106 to engage and retract soft tissue. With soft tissue engagement, the physician can move the retractor 2 toward the inner wall surface 116 (and thus also toward the locking spring 16) and can magnetically engage selected ones of the magnets 35 with the locking spring 16 (or at least with a ferrous portion thereof) to attach the retractor to the inner wall surface 116. In additional embodiments, the retractor 2 can be constructed of a ferrous material and the locking spring 16 can carry one or more magnets. In other embodiments, the retractor 2 and the locking spring 16 may carry opposite polarity magnets for attachment therebetween.
Referring now to fig. 4A-4D, the surgical access system 100 can include an instrument 300 releasably coupled to the retractor body 3 for manipulating the retractor body 3 so as to engage and retract soft tissue using the distal end 6 thereof. Instrument 300 includes a handle 302 that extends in a forward direction FD from a rear end 304 of instrument 300 to a coupling mechanism 308 at a front end 306 of instrument 300. The coupling mechanism 300 releasably couples the instrument 300 to the retractor body 3. For example, the coupling mechanism 308 may be configured to alternate between: a coupled configuration (shown in fig. 4A-4C) in which the instrument 300 is rigidly coupled to the retractor body 3; and an uncoupled configuration (shown in fig. 4D) in which the instrument 300 is uncoupled from the retractor body 3 and removable therefrom, as described in greater detail below.
The instrument 300 may also be configured to operatively couple to an attachment device 314 of the retractor body 3. As described above, the attachment device 314 is configured to attach the retractor body 3 to the access member 102, particularly the inner wall surface 116, after the distal end 6 of the retractor body 3 has thereby engaged the soft tissue to be retracted. In this embodiment, the attachment device 314 may have a proximal mount 316 and a distal mount 318 configured to mount to the proximal end 110 and the distal end 112, respectively, of the access member wall 104. Proximal mount 316 defines one or more mating surfaces 317 configured to engage one or more complementary mating surfaces 307 defined at the leading end 306 of instrument 300. The mating surfaces 307, 317 may be aligned with the axial and longitudinal directions, respectively, allowing the instrument 300 to lift off the proximal mount 316 in the longitudinal direction L when in the uncoupled configuration, as shown in fig. 4D.
Referring now to fig. 4E, the proximal and distal mounts 316, 318 can each include engagement members 320a, 320b configured to engage the access member 102, such as at the proximal and distal ends 110, 112 thereof, in a manner that secures the attachment device 314 (and thus also the retractor body 3) to the wall 104. As shown, each of the engagement members 320a, 320b may be a hook configured to hook or otherwise latch onto the respective proximal and distal ends 110, 112 of the access member 102. Additionally, at least one of proximal mount 316 and distal mount 318 (such as their engagement members 320a, 320b) may be configured to move between: an unlocked configuration, wherein proximal mount 316 and distal mount 318 are longitudinally spaced from one another by a first distance L1; and a locked configuration in which the proximal mount and the distal mount are longitudinally spaced from one another by a second distance L2 that is less than the first distance L1. In particular, the second distance L2 corresponds to the distance between the proximal end 110 and the distal end 112 of the wall 104 in the axial direction X. In this way, the proximal mount 116 and distal mount 118 can be configured to achieve a secure grip for the access member 102 to which the retractor body 3 is attached.
Referring now to fig. 4F, actuator 330 can include a biasing mechanism 331 for biasing one or both of proximal mount 316 and distal mount 318 into a locked or unlocked configuration. In the illustrated embodiment, the biasing mechanism 331 includes a spring assembly 332 that includes at least one spring 334, such as a pair of springs 334 that apply a biasing force to the engagement member 320a in a biasing direction (such as the distal direction D) away from the mounting base 322 to actuate the engagement member 320a to the locked configuration. Spring assembly 332 may also include one or more spring guide members 336, such as a pair of guide rods 336 or dowels, that extend centrally through spring 334 as illustrated and are configured to guide movement of engagement member 320a in longitudinal direction L toward and away from mounting base 322.
The coupling mechanism 308 of the instrument 300 may be configured to move the actuator 330 in the following manner: actuation of one or both of the proximal and distal mounts 316, 318 between the locked and unlocked configurations is facilitated or at least facilitated. For example, in the illustrated embodiment, coupling mechanism 308 can include one or more moving members, such as a pair of arms 340, configured to be operably connected to engagement member 320a of proximal mount 316 in a manner that facilitates movement of engagement member 320a relative to mounting base 322, as described in more detail below. As illustrated, the arms 340 can be spaced apart from one another in the transverse direction a and can translate relative to the handle 302, such as in an arm translation direction having at least a directional component in the forward direction FD and/or the rearward direction RD opposite the forward direction FD. The arms 340 may travel along complementary guide formations, such as guide slots 342 defined in the body 305 of the handle 302. As shown, the guide slot 342 and the arm 340 may have complementary dovetail geometries.
Referring now to fig. 4G, arms 340 may be coupled together by a yoke member 344, which may also couple arms 340 to a center arm 346 that is biased in either a forward direction FD or a rearward direction RD. In the illustrated embodiment, the coupling mechanism 308 includes an arm biasing member 348, such as a spring, that may reside in a slot 350 centrally defined within the handle body 305. The depicted biasing member 348 is a compression spring that engages the center arm 346 to bias the center arm and thus the arm 340 in the forward direction FD into a coupled configuration with the retractor body 3. In this embodiment, when in the coupled configuration, the distal end 341 of the arm 340 is engaged with and coupled to a mounting base 322 that rigidly couples the instrument 300 to the retractor body 3. As illustrated, when in the coupled configuration, the distal ends 341 of the arms 340 may extend within complementary receptacles 326 in the mounting base 322 (see also fig. 4C). The arm 340 is also configured to translate in the rearward direction RD to withdraw the distal end 341 of the arm 340 from the receptacle 326 of the mounting base 322 to move the instrument 300 into the uncoupled configuration. In this manner, the arm 340 may be translated in the forward direction FD and the rearward direction RD to alternate the coupling mechanism 308 between the coupled and uncoupled configurations. The outer surface of the arms may include grip enhancing features 352, such as serrations, for facilitating manual retraction of the arms 340. As shown in fig. 4D, when the distal end 341 of the arm 340 faces away from the receptacle 326 of the mounting base 322, the instrument 300 may move away from the attachment device 314, which remains attached to the access member 102.
Referring now to fig. 4H, while coupling mechanism 308 is in a coupled configuration with mounting base 322, instrument 300 can also be configured to engage actuator 330 for moving engagement member 320a relative to mounting base 322, such as to an unlocked configuration. As illustrated, the center arm 346 is operatively connected to the return member 335 of the biasing mechanism 331. The return member 335 is configured to move the engagement member 320a toward the mounting base 322 in a direction opposite the biasing direction (such as a proximal direction P opposite the distal direction D) so as to move the engagement member 320a to the unlocked configuration. The return member 335 may be an elongated member that extends proximally from the engagement member 320a of the proximal mount 316 and through the opening 309 at the forward end 306 of the instrument 300 and into the chamber 311 defined within the handle body 305. An opening 309 may be defined between the handle body 305 and a base member 322 of the proximal mount 316. As illustrated, the return member 335 may be integral with the engagement member 320a, or alternatively may be a separate member connected to the engagement member 320 a.
The button 360 may include one or more extensions or legs 366, such as a pair of legs 366 spanning the central arm 346. At least one of the button legs 366 can include a cam projection 367 configured to travel along a complementary groove 369 defined in the connector 337. The connector 337 can be pivotably coupled to the center arm 346 via a pin joint 347 such that when the button 360 is depressed, the cam 367 and the groove 369 engage to pivot the connector 337 about the pin joint 347 such that the forward end 337a of the connector 337 pulls the return member 335 in the proximal direction P against the biasing force to move the engagement member 320a of the proximal mount 316 to the unlocked configuration. Additionally, when button 360 alternates to its neutral position, cam 367 and groove 369 engage to pivot connector 337 about pin joint 347 in the opposite direction, thereby allowing biasing mechanism 331 to return engagement member 320a to the locked configuration. Thus, the physician can operate button 360 to move proximal mount 316 between the locked and unlocked configurations as desired. It will be appreciated that the forward end 337a of the connector 337 is configured to be distal from the receptacle 339 in the rearward direction RD when the instrument 300 is in the uncoupled configuration. Thus, moving the arm 340 in the forward direction FD and the rearward direction RD causes the coupling mechanism 308 to alternate the engagement and disengagement of the connector 337 with the return member 335 between the coupled configuration and the uncoupled configuration.
The operation of the instrument 300 to retract soft tissue at the treatment site will now be described. The instrument 300 can be used to insert the retractor body 3 through the working channel 106 to engage and retract soft tissue. In particular, the physician can manipulate the retractor body 3 to engage and retract soft tissue via the handle 302. Once the soft tissue is engaged, the physician may use the instrument 300 to pull the soft tissue toward the wall 104. The design of the attachment means 314 allows the physician to choose whether to first secure the proximal mount 316 or the distal mount 318 to the respective proximal end 110 or distal end 112 of the access member 102. The selected mount 316, 318 is secured to the respective end 110, 112 of the access member 102 by engaging the end 110, 112 with the hooks 320a, 320b of the mounts 316, 318. To secure the selected mount 316, 318 to the respective end 110, 112 of the access member 102, the practitioner can depress button 360 to move the engagement member 320 of the proximal mount 316 to the unlocked configuration. It should be appreciated that with one of the mounts 316, 318 fixed, the practitioner may optionally use the fixed mount 316, 318 as a pivot or fulcrum to align the other of the proximal and distal mounts 316, 318 with the respective end 110, 112 of the access member 102. With both mounts 316, 318 aligned with ends 110, 112 of access member 102, the practitioner can then release button 360, allowing biasing mechanism 331 to bias proximal engagement member 320a away from mounting base 322 in a manner that reduces the longitudinal distance between mounts 316, 318 until both mounts 316, 318 are secured to ends 110, 112 of access member 102 in a locked configuration.
Referring now to fig. 4I-4K, the attachment device 314 can be configured to allow the retractor body 3 to translate in the longitudinal direction L relative to the access member 102 while attached to the wall 104. For example, the attachment device 314 may include one or more elongate members 370, such as a pair of rods, extending within the working channel 106 from the proximal mount 316 to the distal mount 318. The rods 370 are spaced from each other in the lateral direction a so that the retractor body 3 can extend between the rods 370. One or both of the proximal and distal mounts 316, 318 can include a guide feature, such as a guide shoe 372 that engages the sides 20, 22 of the retractor body 3. For example, the guide shoes 372 and sides 20, 22 of the retractor body 3 may have complementary shapes to guide the retractor body 3 in translation in the longitudinal direction L. One or both of proximal mount 316 and distal mount 318 may also define a guide channel 374 having a complementary geometry to retractor body 3 for further guiding its translational movement 3 in longitudinal direction L.
The attachment means 314 may comprise a retaining mechanism for maintaining the relative longitudinal position between the retractor body 3 and the attachment means 314. For example, as shown in fig. 4H, base member 322 can include a flexible tab or pawl 380 having teeth 382 at a distal free end of pawl 380. The teeth 382 are configured to continuously engage a longitudinal series of complementary ratchet grooves 384 defined in the outer surface 12 of the retractor body 3 as the retractor body 3 translates relative to the mounting base 322. The teeth 382 and ratchet groove 384 may have complementary geometries that allow the physician to manually longitudinally translate the retractor body 3 relative to the attachment device 314 as desired, but provide sufficient resistance to maintain the relative longitudinal position between the retractor body 3 and the attachment device 314 after the physician stops manipulating the retractor body 3. It will be appreciated that the complementary geometry of the teeth 382 and ratchet groove 384 can be tailored as required to provide the required amount of resistance to relative longitudinal movement between the attachment means 314 and the retractor body 3.
Referring now to fig. 5A, another embodiment of the surgical access system 100 is shown including an instrument 400 releasably coupled to the retractor body 3. As with the embodiments described above, instrument 400 is configured to alternate between: a coupled configuration, in which the instrument is coupled to the retractor body 3; and an uncoupled configuration, in which the instrument 400 is uncoupled from the retractor body 3 and can be removed therefrom. For the sake of brevity, the following disclosure will focus on the differences between this embodiment and the embodiment described above with reference to fig. 4A-4K.
In this embodiment, the retractor body 3 carries an attachment device 414 that is operable between a locked configuration and a non-locked configuration independently of the operation of the instrument 400. As illustrated, the attachment device 414 includes a proximal mount 416 and a distal mount 418 that may each have a hook geometry for engaging the proximal end 110, the distal end 112 of the access member 102. An elongate actuator 430 extends proximally from distal mount 418 through the receptacle defined by proximal mount 416 and to a control member 435 spaced from proximal mount 416 in proximal direction P. The elongate actuator 430 can be a rod that can be rigidly coupled to the distal mount 418 and configured to slide the distal mount 418 along the retractor body 3 and relative to the proximal mount 416 in order to adjust the longitudinal distance between the proximal mount 416 and the distal mount 418 as needed for attachment to the access member 102. The control member 435 may be a finger tab that allows a push-push operation of the elongated actuator 430 in the longitudinal direction L.
The instrument 400 can be used to insert the retractor body 3 through the working channel 106 to engage and retract soft tissue. As above, once engaging the soft tissue, the physician may use the instrument 400 to pull the soft tissue toward the wall 104, thereby choosing to first secure the proximal mount 416 or the distal mount 418 to the respective proximal end 110 or distal end 112 of the access member 102 by hooking the ends 110, 112 with the hooks of the mounts 416, 418. From this position, the practitioner can align the other of the proximal and distal mounts 416, 418 with the respective ends 110, 112 of the access member 102, and then operate the control member 435 to reduce the longitudinal distance between the mounts 416, 418 until both mounts 416, 418 are secured to the ends 110, 112 of the access member 102 in a locked configuration. The proximal and distal mounts 316, 318 preferably each define a guide channel 474 (shown in fig. 5B) having a complementary geometry to the retractor body 3 for further guiding translational movement of the retractor body 3 in the longitudinal direction L at least after decoupling of the instrument 400 from the attachment device 414.
Referring now to fig. 5B, the instrument 400 includes a coupling mechanism 408 that is directly coupled to the retractor body 3. Specifically, the instrument 400 has an instrument body 405 with a mounting sleeve 410 at its forward end 406. The mounting sleeve 410 defines a receptacle 411 configured to receive a proximal portion of the retractor body 3 in the proximal direction P. In addition, the coupling mechanism 408 includes a locking pin 422 that resides within a pin receptacle 424 defined within the instrument body 405 along a pin axis 435. The pins 425 may be oriented in the transverse direction T. The pin receptacles 424 are aligned with locking holes 426 defined in the front portion of the mounting sleeve 410. In this embodiment, the retractor body 3 defines a locking aperture 7 extending in the transverse direction T from the inner surface 10 to the outer surface 12. The proximal end 4 of the retractor body 3 can be inserted in the proximal direction P within the mounting sleeve 410 until the locking apertures 7 are aligned with the locking pins 422. Once aligned, the locking pin 422 can be advanced from an uncoupled configuration in which the pin 422 is distal from the locking aperture 7 to a coupled configuration in which the locking pin 422 extends through the locking aperture 7 of the retractor body 3 and into the locking hole 426.
The locking pin 422 may be alternated between the coupled and uncoupled configurations by the button 460 moving along the button axis 465 between a first button position and a second button position. The button axis 465 may be angularly oriented with respect to the pin axis 425. As illustrated, the button 460 and the pin 422 may define a complementary cam mechanism that may include a side pin or protrusion that extends laterally from the pin 422 and into a cam groove 467 defined in the body 469 of the button 460. In this manner, alternating movement of the button 460 along its axis 465 may drive alternating movement of the locking pin 422 along its axis 425 between the coupled and uncoupled configurations. It will be appreciated that a biasing member (such as a spring) may extend between the button 460 and the instrument body 305, which may operate in a complementary manner with the cam mechanism to effectively switch the locking pin 422 between the coupled and uncoupled configurations.
Referring now to fig. 6A-6F, the instrument 400 described above may be configured to employ a tension actuator, such as a suturing member 431, for pulling the distal mount 418 toward the proximal mount 416 and moving the attachment device 414 into a locked configuration. In such embodiments, the distal mount 418 can include one or more receiving formations for receiving at least a portion of the suturing member 431. Such containment formations may include one or more apertures 470 defined by distal mounting member 418, such as a pair of apertures 470 spaced from one another along lateral direction a. The pair of apertures 470 may extend through a rear portion of distal mount 418 in a direction having at least a directional component in transverse direction T. Suture member 431 can pass through aperture 470 so as to define one or more suture leads 434, such as a pair of suture leads 434, which can be operably coupled to proximal mount 416. Proximal mount 416 may include one or more additional receiving formations 437, such as suture channels, cleats, or the like, for receiving and securing one or more suture leads 434 thereto. The instrument 400 may also include additional receiving formations, such as channels, cleats, or the like, for receiving and/or securing the free ends of one or more suture leads 434 extending from the proximal mount 416, thereby allowing the physician to secure the one or more suture leads 434 relative to the instrument 400 in a fixed, but non-locked configuration.
As shown in fig. 6E, one or more receptacle formations 437 of proximal mount 416 can be configured such that a respective suture lead 434 can be locked therewith via friction. The suture member 431 may extend from its first end 439a through a first receiving formation 437 at the proximal mount 416, along the retractor body 3 in the longitudinal direction L, through an aperture 470 in the distal mount 418, again along the retractor body 3 and back toward the proximal mount 416, through a second receiving formation 437 at the proximal mount 416, and to a second end 439b of the suture member 431 opposite the first end 439 a. In this manner, the suture lead 434 adjacent the second end 439b can be manipulated by the physician to tension the suture member 431 to pull the distal mount 418 toward the proximal mount 416 to move the attachment device 414 into the locked configuration. Once in the locked configuration, suture lead 434 adjacent second end 439b may be secured to second receiving formation 437, thereby locking attachment device 414 in the locked configuration. It will be appreciated that first end 439a of suturing member 431 may be tethered or otherwise configured as a knot for holding first end 439a at first receptacle formation 437. Further, the second end 439b of the suturing member 431 can optionally be coupled to a pulling member, such as a rigid ring or collar, for assisting the physician in tensioning the suturing member 431.
In the unlocked configuration, the instrument 400 can be used to insert the retractor body 3 through the working channel 106 to engage and retract soft tissue. Once the soft tissue is engaged, the physician may use the instrument 400 to pull the soft tissue toward the wall 104. During this procedure, the practitioner may choose to secure at least one of the proximal mount 416 and the distal mount 418 to the respective proximal end 110 and/or distal end 112 of the access member 102, such as by hooking the ends with hooks of the mounts 416, 418. As above, the design of the attachment device 414 allows the physician to first hook the proximal mount 416 or the distal mount 418 to the respective end 110, 112. From this position, the practitioner can align the other of the proximal mount 416 and the distal mount 418 with the respective end of its access member 102, and then apply tension to the suture member 431, such as by pulling on the free suture lead 434 adjacent the second end 439b, until the proximal mount 416 and the distal mount 418 are secured to the ends 110, 112 of the access member 102 in a locked configuration, as illustrated in fig. 6D. From this position, the physician can attach free suture lead 434 to second receiving formation 437 of proximal mount 416 (such that two sutures 434 are secured to proximal mount 416), thereby maintaining mounts 416, 418 in a locked configuration. The physician may also detach one or both of the ends 439a, 439b of the suture lead 434 from the receiving formations of the instrument 400, thereby allowing the instrument 400 to be decoupled from the proximal mount 416 with the proximal mount 416 and the distal mount 418 secured in a locked configuration.
Similarly, as described above, proximal mount 416 and distal mount 418 preferably each define a guide channel having a complementary geometry to retractor body 3 for guiding translational movement of retractor body 3 relative to mounts 416, 418 in longitudinal direction L after instrument 400 is decoupled from proximal mount 416. For example, as shown in fig. 6F, one or both of the proximal and distal mounts 416, 418 can define a channel 474 having trapezoidal channel sidewalls 475 that retain the retractor body 3 within the channel 474 while allowing longitudinal translation of the retractor body 3 relative to the mounts. In addition, the outer surface 12 of the retractor body 3 can optionally define a longitudinal channel or groove 492 configured to receive the suture member 431. It will also be appreciated that the instrument 400 of this embodiment may employ the same or similar coupling mechanisms as the coupling mechanisms 408 described above with reference to fig. 5B for selective direct coupling to and decoupling from the retractor body 3. In such embodiments, the proximal mount 416 may be rigidly attached to the mounting sleeve 410 of the coupling mechanism. It should also be appreciated that in additional embodiments, the instrument 400 described above with reference to fig. 6A-6F may be configured to employ a stretch actuator, which may alternatively be an elastic member, such as an elastic band, by way of non-limiting example.
Referring now to fig. 7A-7C, surgical access system 100 can include an attachment device 714 having a proximal mount 716 and a distal mount 718 and employing a retaining mechanism, such as a ratchet or ratchet-like mechanism, for securing mounts 716, 718 in a locked configuration to access member 102. Similar to the embodiment described above with reference to fig. 4A-6D, one or both of the proximal mount 716 and distal mount 718 of the present embodiment are configured to alternate between an unlocked configuration and a locked configuration. Additionally, as above, the mounts 716, 718 include engagement members 720a, 720b, such as hooks, configured to hook, latch, or otherwise secure to the respective proximal and distal ends 110, 112 of the access member 102 when in the locked configuration. For the sake of brevity, the following disclosure will focus on the differences between this embodiment and the embodiment described above with reference to fig. 4A-6D.
As shown in fig. 7A, each of the proximal and distal mounting members 716, 718 can include an elongate body portion 719 that is elongated along the longitudinal direction L and conformally shaped with the outer surface 12 of the retractor body 3 for guiding translational movement of the retractor body 3 relative to the mounting members 716, 718. The elongated body portions 719a, 719b are configured to extend within the working channel 106 and reside between the retractor body 3 and the inner wall surface 116 of the access member 102. The proximal mount 716 can also include an elongated handle portion 702 extending from the elongated body portion 719a and configured to allow a physician to manipulate the retractor body 3 for engaging soft tissue at a treatment site. For example, the elongated handle portion 702 may be configured for manipulation by a physician's index finger. As shown in fig. 7B, in other embodiments, the handle portion 702 may have a circular shape. In yet other embodiments, the handle portion 702 may be configured to deflect between at least one of an elongated configuration (fig. 7A) and a circular configuration (fig. 7B) and another configuration.
The attachment arrangement 714 includes an elongate actuator 730 that extends proximally from the distal mount 718, through and/or along the proximal mount 716, and to a control member 735 that is spaced from the proximal mount 716 in the proximal direction P. As illustrated, the elongate actuator 430 can be a pair of rods 731 that can be rigidly coupled to the distal mount 718 and configured to move the distal mount 718 along the retractor body 3 and relative to the proximal mount 716 to alternate the mounts 716, 718 between a locked configuration and a non-locked configuration, similar to that described above with reference to fig. 5A. As above, the control member 735 may be a finger tab that allows the actuator lever 731 to perform a push-push operation in the longitudinal direction L. For example, the control member 735 may be configured for manipulation by a thumb of a physician, while the handle portion 702 is configured for manipulation by an index finger of the physician. As shown in fig. 7C, the actuator rod 731 can extend through a guide channel 737 defined in the outer surface 12 of the retractor body 3. The actuation rod 731 may also extend through a complementary guide channel 739 defined by the elongate body portion 719a of the proximal mounting member 716. In this manner, the actuator rod 731 can translate the distal mount 716 relative to the proximal mount 716.
Referring now to fig. 7D and 7E, the retractor body 3 and the proximal and distal mounts 716, 718 can include guide features for guiding translational movement of the retractor body 3 relative to the mounts 716, 718, and vice versa, such as for translating the retractor body 3 relative to the access member 102. For example, the retractor body 3 may define a slot 740 that is elongated in the longitudinal direction L. The mounts 716, 718 can each include a sliding member 742 that extends from the respective elongate body portions 719a, 719b and within the slot 740 and is configured to travel longitudinally along the slot. Within the slot 740, the retractor body 3 can define side walls 744 that slope inwardly toward one another, and the sliding member 742 can have an expanded geometry that complements the sloped geometry of the side walls 744 in a dovetail fashion. In this manner, the side walls 744 can retain the sliding member 742 within the slot 740, thus also maintaining the proximal and distal mounts 716, 718 in engagement with the outer surface 12 of the retractor body 3.
Referring now to fig. 7F-7H, a retaining mechanism for selectively retaining the relative longitudinal position between the proximal and distal mounts 716, 718 will now be described. The retractor body 3 can define, for example, a series of ratchet grooves 750 disposed longitudinally along the slot 740 and configured to engage at least one complementary ratchet tooth 752 of at least one of the proximal mount 716 and the distal mount 718. The ratchet groove 750 can be defined in the outer surface 12 of the retractor body 3 and can also be defined at least in part by a sidewall 744 within the slot 740.
As shown in fig. 7G and 7H, the ratchet teeth 752 may extend from a flexible tab 754, which may also be referred to as a "pawl," and which may be defined by the elongate body portion 719a of the proximal mount 716. The ratchet teeth 752 are configured to selectively engage at least one of the ratchet grooves 750 and at most each ratchet groove in succession as the proximal mount 716 is longitudinally translated relative to the retractor body 3. The ratchet teeth 752 may be located at a first end 756 of the pawl 754 opposite a second end 758 of the pawl 754. The second end 758 may include the hook 320a of the proximal mount 716. The detent 754 may reside within a recess of the cutout 760 defined by the elongate body portion 719 a. The pawl 754 may be connected to the remainder of the elongate body portion 719a by a pair of arms 762 that oppose each other in the lateral direction a. The pair of arms 762 may provide a degree of rotational flexibility for the pawl 752 along a plane defined by the longitudinal and transverse directions T. In this manner, the pawl 754 may be configured to alternate between: an intermediate or engaged configuration (as shown in fig. 7G) in which the teeth 752 reside within one of the ratchet grooves 750 so as to maintain the relative longitudinal position between the proximal mount 716 and the retractor body 3; and a flexed or disengaged configuration in which the teeth 752 are distal from each of the ratchet grooves 750.
The teeth 752 and ratchet groove 750 can have complementary geometries that provide substantially equal resistance to proximal or distal movement of the proximal mount 716 relative to the retractor body 3. It will be appreciated that the complementary geometry of the teeth 752 and ratchet groove 750 can be customized as desired to provide a desired amount of resistance to relative longitudinal movement between the proximal mounting member 716 and the retractor body 3. In other embodiments, the teeth 752 and ratchet groove 750 may have complementary geometries that prevent proximal movement of the proximal mount 716 relative to the retractor body 3 in the engaged configuration. In such embodiments, the pawl 754 can optionally include a disengagement feature for manually rotating the pawl 754 to a disengaged configuration. It will be appreciated that the retaining mechanism of the previous embodiments can provide audible and/or tactile feedback regarding the relative longitudinal movement between the proximal mount 716 and the retractor body 3 as the teeth 752 continuously "click" into and out of the ratchet groove 750. It should be appreciated that in other embodiments, controlled movement of the proximal and distal mounts 716, 718 relative to one another may be used in a friction-based retention mechanism.
The operation of the retractor 2 of this embodiment will now be described. The handle portion 702 can be used to insert the retractor body 3 through the working channel 106 to engage and retract soft tissue. Once engaged with the soft tissue, the physician may use the handle portion 702 to pull the soft tissue toward the wall 104, thereby choosing to first secure the proximal mount 716 or the distal mount 718 to the respective proximal end 110 or distal end 112 of the access member 102 by hooking the ends 110, 112 with the hooks of the mounts 716, 718. From this position, the practitioner can align the other of the proximal and distal mounts 716, 718 with the respective ends 110, 112 of the access member 102, and then operate the control member 735 to reduce the longitudinal distance between the mounts 716, 718, thereby causing the ratchet teeth 752 to sequentially engage the ratchet grooves 750 until both mounts 716, 718 are secured to the ends 110, 112 of the access member 102 in a locked configuration.
It will be appreciated that each of the embodiments described above with reference to fig. 4A-7H allows for multiple retractors 2 to be attached to various selected circumferential locations of the access member 102 simultaneously, with the respective attachment devices 314, 414, 714 attached to the ends 110, 112 of the access member 102.
Referring now to fig. 8A-8C, the surgical access system 100 can include a suction attachment device 814 configured to selectively attach the retractor body 3 to a circumferential portion of the inner wall 116 of the access member 102. For example, the retractor body 3 can define an interior chamber 816 in fluid communication with a plurality of vacuum ports 818 defined in the exterior surface 12 of the retractor body 3. The internal chamber 816 is also in fluid communication with a proximal port 820, which may be connected to a tubing 822, which may in turn be connected to a vacuum source 824, such as a vacuum pump. A plurality of ring seals 826 are located in the vacuum ports 818 and are configured to provide sealing engagement with the inner wall surface 116 when the ring seals 826 are in contact with the inner wall surface 116, and a vacuum source 824 supplies vacuum pressure to the interior chamber 816 and thus also to the vacuum ports 818. The suction attachment device 814 can be configured to provide a customized adequate suction force to allow the retractor body 3 to translate at least longitudinally relative to the access member 102 while the retractor body 3 remains attached to the access member 102 via the suction attachment device 814. It will be appreciated that the present embodiment allows multiple retractors 2 to be attached to various selected circumferential locations of the inner wall surface 116 simultaneously via suction.
Referring now to fig. 9A-9C, the surgical access system 100 can include an attachment device 914 that employs mating engagement between a protrusion 920 and an opening 922 for selective attachment of the retractor body 3 to a circumferential portion of the access member 102. For example, at least one of the inner wall surface 116 and the retractor body 3 can define one or more openings 922, and the other of the inner wall surface 116 and the retractor body 3 can include one or more protrusions 920 complementary to the one or more openings 922. In other words, the one or more protrusions 920 are configured for insertion into the one or more openings 922 in order to couple the retractor body 3 to the access member 102.
As shown in fig. 9A, the wall 104 of the access member 102 can define an array 924 of openings 922, and the retractor 2 can include a series of projections 920 for engagement within selected ones of the openings 922. The protrusion 920 may be defined by the retractor body 3 and be integral therewith, or may be carried by an insert that may be connected to the retractor body 3. The protrusions 920 extend outwardly from the outer surface 12 of the retractor body 3 and are aligned with each other in the longitudinal direction L. The openings 922 may each extend outwardly from their inner surface 116 into the wall. The array 924 may include one or more columns 926 of openings 922 and one or more rows 928 of openings 922. In each column 926, the openings may be aligned with one another along the longitudinal direction L. Accordingly, each column 926 may be characterized as defining a longitudinally aligned subset of the openings 922 in the array 924. The columns 926 are circumferentially spaced from one another along the wall 104. In each row 928, the openings 922 may be aligned in the lateral direction a. Accordingly, each row 928 can be characterized as defining a laterally-aligned subset of the openings 922 in the array 924. The rows 928 are spaced apart from each other in the axial direction X of the access member 2 (and also in the longitudinal direction L of the retractor 2 when the retractor 2 is attached to the access member 102). In the embodiment shown in fig. 9A, the protrusions 920 are configured for insertion into any one of the columns 926 to selectively attach the retractor body 3 to a circumferential portion of the access member 102. It will be appreciated that the retractor 2 may have fewer protrusions 920 than the number of openings 922 in the row 926. In such embodiments, the retractor 2 can also be selectively attached to the access member 102 at a selected depth (i.e., a selected longitudinal position).
The protrusion 920 may optionally define a handle 930 extending from the retractor 2, and a head 932 at the outer end of the handle 930 and wider than the handle 930. As shown in fig. 9B, the opening 922 may extend radially through the wall 104 from the inner wall surface 116 to the outer wall surface 114. In such embodiments, the protrusion 920 can be configured such that the handle 930 extends through the opening 922 and at least a portion of the head 932 is radially outward of the outer wall surface 114 when the retractor body 3 is attached to the access member 102. As shown, the stem 930 may be long enough so that the entire head 932 is radially outward of the wall 102. In such embodiments, at least a portion of the head 932 may overlap at least a portion of the wall 104 in the axial direction X of the access member 102 (and thus also in the longitudinal direction L of the retractor 2) when the retractor 2 is attached to the access member wall 104. Thus, the protrusion 920 and the opening 922 may be cooperatively configured to resist inadvertent disassembly of the retractor 2 from the access member wall 104 in the transverse direction T.
In other embodiments, as shown in fig. 9C, the opening 922 may extend from the inner wall surface 116 and terminate at a location radially inward of the outer wall surface 114. In such embodiments, the opening 922 may include an axial receptacle 934 configured to receive a portion of the mating head 932 such that at least a portion of the head 932 overlaps at least a portion of the wall 104 in the axial direction X and the longitudinal direction L, respectively, as described above. It should be understood that other complementary protrusion 920 and opening 922 geometries for providing a strong, selective attachment of the retractor 2 to the access member wall 104 are within the scope of the present disclosure. It should also be appreciated that in other embodiments, the protrusion 920 may extend inwardly from the inner wall surface 116 of the access member 102 and the opening 922 may be defined in the retractor body 3.
During a surgical procedure using the surgical access system 100 of this embodiment, a physician may insert the retractor body 3 through the working channel 106 to engage and retract soft tissue. Once engaged with the soft tissue, the physician may manipulate the proximal end 4 of the retractor 2 to pull the soft tissue toward the wall 104. Specifically, the practitioner can identify the column 926 of openings 922 in the inner wall surface 116 that is substantially radially aligned with the desired retraction direction for coupling with the protrusion 920 of the retractor 2. The practitioner may then insert the protrusion 920 of the retractor 2 into the selected opening 922 of the column 926 at the desired longitudinal position of the retractor 2 relative to the access member 102, thereby attaching the retractor 2 to the inner wall surface 116 at the selected circumferential and longitudinal position of the inner wall surface 116. It will be appreciated that a plurality of retractors 2 may be attached to the inner wall surface 116 in a similar manner to retract soft tissue as desired.
Referring now to fig. 9D and 9E, additional embodiments are shown in which one or more protrusions 920 extend proximally from the proximal surface 111 of the access member 102. The proximal surface 111 may define the proximal end 110 of the access member 102. In such embodiments, the one or more protrusions 920 can include a plurality of protrusions 920 circumferentially spaced from one another along the proximal surface 111. The proximal surface 111 may be defined by a flange 113 at the proximal end 110 of the access member 102. In this embodiment, the retractor body 3 defines one or more openings 922 extending from the inner surface 10 to the outer surface 12. In particular, the retractor body 3 of this embodiment may be pre-bent or bendable such that the first or proximal portion 3a of the retractor body 3 is angularly offset relative to the second or distal portion 3b of the retractor body 3, as described above with reference to fig. 1C. The proximal portion 3a defines at least one opening 922 that extends along the axial direction X and is therefore matable with a selected one of the protrusions 920 for attaching the retractor body 3 to an associated selected circumferential portion of the access member 102. As illustrated, the proximal and distal portions 3a, 3b of the retractor body 3 may be angularly offset from one another in the L-T plane such that the distal portion 3b extends substantially along the axial direction X through the working channel 106 while the proximal portion 3a is elongated along the radial direction R (or at least along a direction having a directional component along the radial direction R).
In embodiments in which the retractor body 3 is pre-curved, the proximal portion 3a defines a single opening 922. In embodiments where the retractor body 3 is bendable, the retractor body 3 may define a plurality of openings 922 spaced in series along the longitudinal direction L, allowing the practitioner to bend the retractor body 3 at selected longitudinal positions to define respective lengths of the proximal and distal portions 3a, 3b, thereby defining the insertion depth of the distal portion 3b when attached to the retractor body 3. It will be appreciated that the protrusion 920 can have a handle 930 and a head 932, as above, and can be cooperatively configured with the opening 922 such that the head 932 can overlap at least a portion of the retractor body 3 in the radial direction R when the retractor body 3 is attached to the access member 102. Such overlap may increase the stability of the attachment between the retractor body 3 and the access member 102.
During use of the embodiment illustrated in fig. 9D and 9E, a practitioner can identify a protrusion 920 on the proximal surface 111 that is substantially radially aligned with a desired retraction direction for coupling with an opening 922 of the retractor 2. The physician may insert the retractor body 3 through the working channel 106 and engage and retract the soft tissue in the radial direction R, thereby bringing the distal portion 3b of the retractor body 3 towards the inner wall surface. In embodiments where the retractor body 3 is pre-curved, the foregoing steps also align the opening 922 in the curved proximal portion 3a with the selected protrusion 920. In embodiments where the retractor body 3 is bendable, the physician may bend the retractor body 3 at a selected longitudinal position to provide the distal portion 3b with a desired axial depth relative to the access member 102. In either embodiment, upon engagement of the distal portion 3b with soft tissue and movement toward a selected circumferential portion of the inner wall surface 116, the physician may move the proximal portion 3a such that the opening 922 receives the selected protrusion 920, thereby attaching the retractor body 3 to the access member 102 as desired. It will be appreciated that a plurality of retractors 2 may be attached to the access member 102 in a similar manner to retract soft tissue as desired.
Referring now to fig. 10A and 10B, the attachment device 1014 for the surgical access system 100 can include a flexible wire 1050 configured to be inserted into the working channel 106 of the access member 102 in a first or insertion configuration and then deformed into a second or deployed configuration for pushing the retractor body 3 against and securing the retractor body to the inner wall surface 116. For example, the wire 1050 may be preformed into an intermediate shape, such as one or more coils, for example, and may then be loaded into a guiding instrument 1070 (also referred to herein as introducer 1070) that maintains the wire 1050 in the inserted configuration. Introducer 1070, or at least an end portion thereof, may be inserted into working channel 106, and wire 1050 may be deployed (i.e., urged) from introducer 1070 and into working channel 106, with wire 1050 elastically deformed from its inserted configuration to its deployed configuration. This deformation may cause the wire 1050 to form one or more coils extending circumferentially around the inner wall surface 116 and exert a radially outward spring force F that firmly urges the retractor body 3 against the inner wall surface 116 as the wire 1050 attempts to return to its intermediate configuration. In other embodiments, wire 1050 may be configured as a coil spring when in the intermediate configuration, and may also be helically twisted so as to reduce its spring diameter when in the insertion configuration. Once inserted to a desired location within working channel 106, wire 1050 may be released to expand within working channel 106 to a deployed configuration. It should be appreciated that, by way of non-limiting example, the wire 1050 may be composed of a shape memory material (such as nitinol) that is also biocompatible.
The retractor body 3 of any of the preceding embodiments may be constructed of a biocompatible material, including by way of non-limiting example, a metal, a polymer, a composite material, or any combination of the foregoing.
It will be appreciated that the retractor 2 and attachment devices 14, 314, 414, 714, 814, 914 described above allow for selective placement (including in a circumferential and longitudinal manner) of the retractor 2 relative to the access member 102, and thus also relative to the patient anatomy for fine control of the patient anatomy. Such fine control of soft tissue retraction is particularly beneficial because it reduces the need to remove (remove) soft tissue at the treatment site, among other things.
Referring now to fig. 11A and 11B, the retractor member 2 of any of the embodiments described above can include at least one sensor 1102 that is electrically conductive and located at or near the distal end 12 of the retractor 2. The sensors 1102 may be used for nerve monitoring at the treatment site (e.g., to detect the presence, proximity, health, and/or other attributes of nerve tissue), such as to navigate the retractor 2 around (e.g., avoid) the nerve tissue, to safely retract the nerve tissue using the retractor 2, and/or to assess the health of the nerve tissue at the treatment site, as more fully described in the' 253 reference. It should be appreciated that the sensor 1102 may include a single sensor or multiple sensors. The sensor 1102 can be in electrical communication with an electrical lead 1104 located at or near the proximal end 10 of the retractor 2 and configured to transmit electrical information obtained by the sensor to a control unit 1106, which can employ a processor 1108 to interpret the electrical information.
As illustrated in fig. 11A, in one such embodiment employing a sensor 1102, the retractor 2 can include a retractor body 3 constructed of an electrically conductive material. The retractor 2 may also comprise an electrically insulating sheath 1110 disposed over the main portion 3i of the retractor body 3. The sheath 1110 can be configured to provide an exposed portion 3j of the retractor body 3 that defines the sensor 1102. The exposed portion 3j may extend from the sheath 1110 to the distal end 12. The sheath 1110 can also be configured to provide another exposed portion 3k of the retractor body 3 defining an electrical lead 1104, which can extend from the sheath 1110 to the proximal end 10. It will be appreciated that as an alternative to the sheath 1110, the retractor body 3 may be coated with a layer of insulating material that may be formed or finished so as to provide an exposed portion of the retractor body 3 at or near the distal end 12 that may define or carry the sensor 1102. The coating can also be configured to provide additional exposed portions of the retractor body 3, such as at or near the proximal end 12 to provide electrical leads 1104.
As shown in fig. 11B, in another embodiment employing a sensor 1102, the retractor 2 can include a retractor body 3 constructed of an electrically insulating material, and the sensor 1102 can be disposed over or embedded within the retractor body 3 at or near the distal end 12 thereof. The electrical leads 1104 may also be disposed over or embedded within the retractor body 3, such as at the proximal end 10 thereof. The retractor 2 can include an electrical transmission element, such as a wire or trace extending from the sensor 1102 to the electrical leads 1104 along or through the retractor body 3.
By way of non-limiting example, the insulation materials described above may include parylene, silicone rubber, fluoropolymers, and elastomers. It should be appreciated that in other implementations employing the sensor 1102, the sensor 1102 may be in wireless communication with the control unit 1106 and/or the processor 1108.
Referring now to fig. 12A-12E, in yet other embodiments, the attachment device 1214 for the surgical access system 100 can include a tether 1211 extending from the proximal end 4 of the retractor body 3. As illustrated in fig. 12A, the retractor body 3 can be carried by an instrument 1200, which can include a distal elongate portion 1205 extending in the longitudinal direction L and carrying the retractor body 3, such as by bracketing the sides of the retractor body 3. The distal elongate portion 1205 is configured for insertion into the access member 102 to engage soft tissue using the retractor body 3. The retractor body 3 can define a distal mount 1218, such as a hook, that can extend from the outer surface 12 of the retractor body 3. Additionally, the distal mount 1218 can be configured to engage the distal end 112 of the access member 102. Additionally or alternatively, the distal mount 1218 can be configured to selectively engage any one of a plurality of slots 1220 defined in the wall 104 of the access member 102, as illustrated in fig. 12D and 12E.
By way of non-limiting example, the tether 1211 may be a wire, a suture member, a string, or a cord. Alternatively, as illustrated in fig. 12C, the tether 1211 may be a band, such as an elastic band. The tether 1211 may be configured to be secured to one or more receiving formations 1215 defined or carried by the access member 102. The receiving formation 1215 can be a receptacle, channel, cleat, etc., that can be defined on the exterior of or carried by the access member 102. Alternatively, as shown in fig. 12D, the receiving formation 1215 may optionally be defined on or carried by an access member retainer 1260 connected to the access member 102. As shown in fig. 12E, the tether 1211 may be attached to the proximal end 110 of the access member 102, alternatively or in addition to receiving the formation 1215, for example, using a spring clip 1270.
Although the present disclosure has been described in detail, it should be understood that various changes, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. For example, features of various embodiments described herein can be incorporated into one or more and up to all other embodiments described herein. Moreover, the scope of the present disclosure is not intended to be limited to the specific embodiments described in the specification. One of ordinary skill in the art will readily appreciate from the disclosure that processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure.
Claims (38)
1. A retractor member configured for insertion through a channel of an access member and for moving soft tissue at a treatment site accessible through the channel, the retractor member comprising:
a body having a proximal end and a distal end and being spaced apart from each other along a longitudinal direction, the distal end defining a retractor blade, the body defining first and second surfaces opposite each other along a transverse direction substantially perpendicular to the longitudinal direction; and
an attachment device configured to selectively attach the body to a portion of the access member such that the body is extendable through a working channel and translatable in the longitudinal direction relative to the access member when the body is attached to the portion of the access member.
2. The retractor member of claim 1, wherein the body has first and second sides spaced from one another along a lateral direction substantially perpendicular to the longitudinal and transverse directions, and the attachment device extends from at least one of the first and second sides at a longitudinal portion of the body intermediate the proximal and distal ends such that the attachment device is configured to reside within the working channel for securing the retractor member to an inner surface of the access member.
3. The retractor member of claim 2, wherein the attachment arrangement includes a pair of wings each extending circumferentially from the first and second sides at the longitudinal portion, respectively, wherein the pair of wings are compliant and configured to flex inwardly toward each other from an intermediate configuration to a flexed configuration by the inner surface of the access member when the pair of wings are seated in the channel such that a return force of the pair of wings urges the pair of wings to engage the inner surface of the access member so as to attach the body to the portion of the access member.
4. The retractor member of claim 3, wherein at the longitudinal portion and in a plane orthogonal to the longitudinal direction, the second surface of the body defines a first radius and the outer surfaces of the wings define another radius that is greater than the first radius when the pair of wings are in the intermediate configuration.
5. The retractor member of claims 3 or 4, wherein the body defines a proximal body portion extending from the pair of wings to the proximal end and a distal body portion extending from the pair of wings to the distal end in the longitudinal direction, and the distal body portion and the proximal body portion are at least partially circumferentially offset from one another.
6. The retractor member of claim 5, wherein the distal body portion and the proximal body portion are fully circumferentially offset from one another.
7. The retractor member of claim 1, wherein the attachment device comprises an attachment member separate from the body, wherein the attachment member comprises:
a slide formation configured to slidably engage a complementary slide formation of the body so as to allow the attachment member to translate along the body and within the channel; and
a locking member extending circumferentially away from the sliding formation, wherein the locking member is compliant and configured to flex inwardly toward a central axis of the entry member when the locking member is seated in the channel such that a return force of the locking member urges the locking member to engage the inner surface of the entry member to attach the body to the portion of the entry member.
8. The retractor member of claim 7, wherein the complementary slide formation of the body comprises a guide slot, the locking member comprises a circumferential wall configured to annularly slide between the outer surface of the body and an inner surface of the access member, wherein the slide formation of the attachment member comprises a slider configured to reside within the guide slot, wherein the slider extends inwardly from the circumferential wall in the transverse direction.
9. The retractor member of claim 1, wherein the attachment device comprises an attachment member separate from the body, at least a portion of the attachment member comprises a magnetic material, and the body comprises one or more magnets each configured for selective attachment to the magnetic material of the at least a portion of the attachment member.
10. The retractor member of claim 1, wherein:
the body defining an interior chamber and further defining a proximal port and a plurality of vacuum ports each in fluid communication with the interior chamber, wherein the plurality of vacuum ports are defined in the second surface and the proximal port is connectable to a vacuum source; and is
The attachment device includes a plurality of ring seals each disposed in one of the plurality of vacuum ports, wherein the plurality of ring seals are configured to sealingly engage an inner wall surface of the access member when vacuum pressure is supplied within the interior chamber.
11. The retractor member of claim 1, wherein the attachment device comprises a wire configured to transition from an insertion configuration to an expanded configuration, wherein the wire is configured to be contained within an elongated insertion device when in the insertion configuration, and the wire is further configured to spring outward so as to extend at least partially circumferentially around an inner wall surface of the access member so as to force the body toward the inner wall surface when in the expanded configuration.
12. The retractor member of claim 1, wherein the body has first and second sides spaced from each other along a lateral direction substantially perpendicular to the longitudinal and transverse directions, the first surface is arcuate and concave between the first and second sides in a plane orthogonal to the longitudinal direction, and the second surface is arcuate and convex between the first and second sides in the plane.
13. The retractor member of claim 12, wherein at least at one of the proximal end and the distal end, the body defines a flared end portion such that the end portion defines a maximum lateral dimension that is greater than a maximum lateral dimension of an adjacent portion of the body that extends from the end portion toward the opposite one of the proximal end and the distal end.
14. The retractor member of claim 12 or 13, wherein at least at one of the proximal end and the distal end, the body defines an end portion that is angularly offset from an adjacent portion of the body that extends from the end portion toward the opposite one of the proximal end and the distal end.
15. The retractor member of claim 14, wherein the end portion is angularly offset from the adjacent portion of the body.
16. The retractor member of claim 1, wherein at least a proximal portion of the body is plastically deformable so as to bend away from a central axis of the access member after the body is attached to the portion of the access member.
17. The retractor member of claim 1, wherein the body comprises at least one conductive sensor at the distal end and the at least one conductive sensor is in electrical communication with an electrical lead spaced from the at least one conductive sensor and configured for communicating sensor information obtained by the at least one sensor to a control unit.
18. The retractor member of claim 17, wherein the body is formed of an electrically conductive material and the retractor member further comprises electrical insulation covering a major portion of the body, wherein the body comprises a distal exposed portion at the distal end, the distal exposed portion defining the at least one electrically conductive sensor, the body further comprises a proximal exposed portion at the proximal end, and the proximal exposed portion defining the electrical lead.
19. The retractor member of claims 17 or 18, wherein the body is formed of an electrically insulating material and the at least one electrically conductive sensor is embedded in the body at the distal end.
20. A system for retracting soft tissue, the system comprising:
an access member having a proximal end and a wall extending from the proximal end to a distal end of the access member, wherein the wall extends about a central axis in a plane orthogonal to the central axis such that an inner surface of the wall defines a channel extending in an axial direction, the axial direction being oriented along the central axis;
a retractor body having a proximal end and a distal end spaced from each other along a longitudinal direction, the distal end configured to engage soft tissue, the body defining first and second surfaces opposite each other along a transverse direction substantially perpendicular to the longitudinal direction; and
an attachment device coupled to the retractor body, the attachment device including a proximal mount and a distal mount configured to be mounted to the proximal end and the distal end of the access member, respectively, wherein at least one of the proximal mount and the distal mount is configured to move between: 1) a non-locking configuration in which the proximal mount and the distal mount are longitudinally spaced from one another by a first distance; and 2) a locked configuration, wherein the proximal mount and the distal mount are longitudinally spaced from one another by a second distance that is less than the first distance, wherein the second distance corresponds to a distance in the axial direction between the proximal end and the distal end of the access member.
21. The system of claim 20, wherein the proximal mount and the distal mount each comprise a hook configured to hook over respective proximal and distal ends of the access member.
22. The system of claim 20 or 21, wherein the retractor body is longitudinally translatable relative to the proximal mount and the distal mount at least when the attachment device is in the locked configuration.
23. The system of any one of claims 20-22, further comprising an actuator configured to actuate the at least one of the proximal mount and the distal mount from the unlocked configuration to the locked configuration.
24. The system of claim 23, wherein the actuator comprises at least one elongate member extending from the distal mount through the receptacle of the proximal mount and to a control member spaced from the proximal mount in a proximal direction oriented along the longitudinal direction, wherein the control member is configured to be manipulated to actuate the at least one of the proximal mount and the distal mount from the unlocked configuration to the locked configuration.
25. The system of claim 23 or 24, wherein the retractor body defines a slot extending in the longitudinal direction, and each of the proximal mount and the distal mount includes a sliding member extending within the slot and configured to slide longitudinally along the slot so as to guide longitudinal movement of the respective mount relative to the retractor body.
26. The system of claim 25, wherein the retractor body further defines a series of ratchet grooves arranged longitudinally along the slot, and the proximal mount comprises a flexible member having teeth configured to engage the series of ratchet grooves, wherein the flexible member is configured to alternate between: 1) an intermediate configuration wherein the tooth resides within one of the ratchet grooves so as to maintain a relative longitudinal position between the proximal mount and the retractor member; and 2) a disengaged configuration in which the teeth are distal from each ratchet groove of the series of ratchet grooves.
27. The system of any one of claims 20 to 25, wherein the proximal mount comprises a handle portion.
28. The system of any one of claims 23 to 27, further comprising an instrument releasably coupled to the attachment device, the instrument comprising:
a handle extending from a rear end of the instrument to a front end of the instrument; and
a coupling mechanism located at least partially at the leading end of the instrument, the coupling mechanism configured to alternate between: 1) a coupled configuration in which the instrument is rigidly coupled to the retractor body; and 2) an uncoupled configuration, wherein the instrument is uncoupled from the retractor body and is removable from the retractor body.
29. The system of claim 28, wherein the coupling mechanism is further configured to move the actuator so as to actuate the at least one of the proximal mount and the distal mount from the unlocked configuration to the locked configuration.
30. The system of claim 28 or 29, wherein the proximal mount comprises a mounting base and an engagement member, wherein the actuator extends between the mounting base and the engagement member and is configured to actuate longitudinal movement of the engagement member relative to the mounting base between the unlocked configuration and the locked configuration.
31. The system of claim 30, wherein:
the actuator includes a biasing mechanism having at least one spring biasing the engagement member in a biasing direction away from the mounting base along the longitudinal direction to actuate the engagement member to the locked configuration;
the biasing mechanism further comprises a return member configured to move the engagement member toward the mounting base and into the unlocked configuration in a direction opposite the biasing direction; and is
The coupling mechanism includes a moving member configured to move the return member in a direction opposite the biasing direction.
32. The system of any of claims 28-31, wherein the retractor body comprises an aperture and the coupling mechanism comprises a pin configured to 1) reside within the aperture to couple with the retractor member when the coupling mechanism is in the coupled configuration; and 2) move away from the aperture to decouple from the retractor member when the coupling mechanism is in the decoupled configuration.
33. The system of claim 32, wherein the coupling mechanism comprises a button connected to the pin and configured to alternate between a first position in which the pin resides within the aperture and a second position in which the pin is distal from the aperture.
34. The system of any one of claims 23 to 33, wherein the actuator is a tension member configured to selectively apply tension between the proximal mount and the distal mount so as to actuate the at least one of the proximal mount and the distal mount.
35. A system for retracting soft tissue, the system comprising:
an access member having a proximal end and a wall extending from the proximal end to a distal end of the access member, wherein the wall extends about a central axis in a plane orthogonal to the central axis such that an inner surface of the wall defines a channel extending in an axial direction, the axial direction being oriented along the central axis;
a retractor body having a proximal end and a distal end spaced from one another along a longitudinal direction, the distal end configured to engage soft tissue, the retractor body defining first and second surfaces opposite one another along a transverse direction substantially perpendicular to the longitudinal direction,
wherein at least one of the access member and the retractor body defines one or more openings and the other of the access member and the retractor body includes one or more protrusions complementary to the one or more openings, wherein the one or more protrusions are configured for insertion within the one or more openings so as to couple the retractor body to the access member.
36. The system of claim 35, wherein each of the one or more protrusions defines a stem and a head extending outwardly from the stem, the head being wider than the stem.
37. The system of claim 35 or 36, wherein:
the one or more openings comprising an array of openings extending outwardly from the inner surface of the wall into the wall, the array defining a plurality of columns, each of the columns comprising a longitudinally-aligned subset of the plurality of openings, wherein the columns are circumferentially spaced from one another along the wall,
the one or more protrusions include a plurality of protrusions that each extend from the second surface of the retractor member in the transverse direction and are aligned with each other in the longitudinal direction, wherein the plurality of protrusions are configured to selectively reside within at least one of the columns such that the head overlaps at least a portion of the wall in the axial direction.
38. The system of claim 35 or 36, wherein:
the retractor body has a proximal portion and a distal portion configured to be angularly offset from each other in a plane extending in the longitudinal and transverse directions, and at least one of the one or more openings extends from the first surface through the proximal portion to the second surface, and
the one or more protrusions include a plurality of protrusions extending in the longitudinal direction from a proximal surface of the access member, wherein the proximal surface is located at a proximal end of the access member, and the plurality of protrusions are circumferentially spaced from one another along the proximal surface.
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2019
- 2019-12-20 US US16/722,480 patent/US11759193B2/en active Active
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2020
- 2020-12-17 AU AU2020404099A patent/AU2020404099A1/en active Pending
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AU2020404099A1 (en) | 2022-08-11 |
WO2021122904A2 (en) | 2021-06-24 |
WO2021122904A3 (en) | 2021-07-29 |
US20230380823A1 (en) | 2023-11-30 |
JP2023506648A (en) | 2023-02-17 |
US20210186477A1 (en) | 2021-06-24 |
EP4076215A2 (en) | 2022-10-26 |
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